BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    16CH AI BREAST COILS 1.5 T AND 3 T

    K Number: K083255 · Decision Nov 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    16CH AI BREAST COILS 1.5 T AND 3 T
    K Number
    K083255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Biomedical GmbH
    Date Received
    November 4, 2008
    Decision Date
    November 21, 2008
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Rapid Biomedical GmbH

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    K191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
    K181948 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
    K163661 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
    K102748 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
    K102348 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T